A Fenac 12.5

Pharmacology

Diclofenac Sodium is an anti-rheumatic, anti-inflammatory, analgesic, and antipyretic non-steroidal anti-inflammatory medication (NSAID). It also contains uricosuric properties. Diclofenac works by inhibiting prostaglandin production, which is a key factor in the development of inflammation, discomfort, and fever. When taken with or after a meal, diclofenac is swiftly and thoroughly absorbed from the gastrointestinal tract. After consumption, peak plasma concentrations are obtained in an average of 2 hours. It is 99.7% bound to plasma proteins at therapeutic dosages. Diclofenac is metabolized in the liver and goes through a first-pass process.

Dosage & Administration

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Contraindications

Patients who are hypersensitive to any of the items' ingredients should avoid using it. Peptic ulcer, hypersensitivity to Diclofenac, as well as other non-steroid anti-inflammatory agents. Diclofenac is also contraindicated in asthmatic patients who have had an attack of asthma, urticaria, or acute rhinitis triggered by acetylsalicylic acid or other drugs that inhibit prostaglandin synthetase. Under occlusive airtight dressings, this Gel should not be utilized.

Side Effects of A-Fenac 12.5

Diclofenac Sodium is well tolerated by most people. Mild, infrequent, and temporary side effects are common. Patients may have epigastric pain, eructation, nausea, and diarrhea, as well as dizziness or headache, during the commencement of treatment. In most cases, these side effects are minor. Edema in the legs and skin responses including rash and eczema have also been reported. Diclofenac Sodium Gel can produce skin irritation, reddening, and a rash on the affected area.

Pregnancy & Lactation

Diclofenac should only be used if absolutely necessary during pregnancy. The smallest dose that is effective should be utilized. These medications are not advised to be taken during the first trimester of pregnancy. Diclofenac Sodium Gel is not suggested during pregnancy due to a lack of clinical evidence. Although a trace amount of Diclofenac may be discovered in breast milk, no adverse effects on the newborn are expected.

Precautions & Warnings

In rare cases, patients using Diclofenac may develop peptic ulcers or experience gastrointestinal bleeding. Patients in their advanced years should be closely monitored. Diclofenac Sodium Gel should not be applied to the eyes or mucous membranes, and the hands should be thoroughly cleansed after application. It should not be consumed by mouth.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.